news/GILD/2023.02.20/Gilead Sciences, Inc. - Trodelvy Demonstrates Positive Efficacy Treating Both Platinum-...txt

FOSTER CITY - Gilead Sciences, Inc. (Nasdaq: GILD) today announced new and updated positive results from three cohorts of the Phase 2 TROPHY-U-01 study of Trodelvy for the treatment of metastatic urothelial cancer.These data demonstrate that Trodelvy produced both rapid and durable responses for patients across a range of hard-to-treat types of mUC including platinum-ineligible and rapidly progressing, post-platinum mUC. These findings will be featured in both an oral session (abstract #520) and in poster presentations (abstract #518, #526) during the 2023 American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO-GU) Annual Meeting February 16-18.'The TROPHY-U-01 data show consistent benefit of Trodelvy across multiple types of metastatic urothelial cancer, including the most difficult-to-treat and, often times, frail patients where treatment options are still scarce,' said Bill Grossman, MD, PhD, Senior Vice President, Therapeutic Area Head, Gilead Oncology. 'Trodelvy has the potential to become a cornerstone treatment in metastatic urothelial cancer, and we are excited about the expected results from the ongoing Phase 3 TROPiCS-04 study that may serve to convert our U.S. accelerated approval to full approval for Trodelvy to treat patients with locally advanced or metastatic urothelial cancer following a platinum-containing chemotherapy and PD-1/PD-L1 inhibitor.'Longer-term follow-up across Cohorts 1, 2, and 3 of TROPHY-U-01 provides an increasing body of evidence supporting the potential benefit of treating mUC with Trodelvy across clinically relevant, hard-to-treat patient populations.In April 2021, the U.S. FDA granted accelerated approval of Trodelvy for use in adult patients with locally advanced or mUC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor. This approval is based on ORR and DOR established in Cohort 1.Trodelvy has not been approved by any regulatory agency for the treatment of platinum-ineligible patients with mUC who progressed after prior CPI therapy, or in combination with pembrolizumab in patients with mUC who progressed after platinum-based therapy. Its safety and efficacy have not been established for these indications.About Metastatic Urothelial CancerUrothelial Cancer (UC) is the most common type of bladder cancer and occurs when the urothelial cells that line the inside of the bladder and other parts of the urinary tract grow unusually or uncontrollably. An estimated 83,000 Americans will be diagnosed with bladder cancer in 20231, and almost 90% of those diagnoses will be UC2. In total, 30% of cases are considered advanced or metastatic disease.3 Despite advancements in treating mUC, long-term survival remains low.About the TROPHY U-01 StudyThe Phase 2 TROPHY-U-01 trial is an ongoing, international, multi-center, open-label, multi-cohort, single-arm study evaluating Trodelvy monotherapy or combination therapy in patients with mUC after progression on a platinum-based regimen and anti-PD-1/PD-L1-based immunotherapy.Cohort 1 is assessing Trodelvy after progression on platinum-based chemotherapy and checkpoint inhibitor (CPI) therapy. Cohorts 2, 3, 4 and 5 of the study are ongoing. Cohort 2 is assessing Trodelvy monotherapy in platinum-ineligible patients after progression on anti-PD-1/PD-L1-based immunotherapy. Cohort 3 is assessing Trodelvy in patients with rapidly progressing, mUC who progressed after platinum-based therapy. Cohorts 4 and 5 are assessing Trodelvy combination therapy in patients with treatment naive mUC, with those in Cohort 4 receiving cisplatin and those in Cohort 5 receiving cisplatin and avelumab, respectively, in addition to Trodelvy.About TrodelvyTrodelvy (sacituzumab govitecan-hziy) is a first-in-class Trop-2 directed antibody-drug conjugate. Trop-2 is a cell surface antigen highly expressed in multiple tumor types, including in more than 90% of breast and bladder cancers. Trodelvy is intentionally designed with a proprietary hydrolyzable linker attached to SN-38, a topoisomerase I inhibitor payload. This unique combination delivers potent activity to both Trop-2 expressing cells and the microenvironment.Trodelvy is approved in more than 40 countries, with multiple additional regulatory reviews underway worldwide, for the treatment of adult patients with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) who have received two or more prior systemic therapies, at least one of them for metastatic disease.Trodelvy is also being developed for potential investigational use in other TNBC, HR+/HER2- and mUC populations, as well as a range of tumor types where Trop-2 is highly expressed, including metastatic non-small cell lung cancer (NSCLC), metastatic small cell lung cancer (SCLC), head and neck cancer, and endometrial cancer.About Gilead SciencesGilead Sciences, Inc. is a biopharmaceutical company that has pursued and achieved breakthroughs in medicine for more than three decades, with the goal of creating a healthier world for all people. The company is committed to advancing innovative medicines to prevent and treat life-threatening diseases, including HIV, viral hepatitis and cancer. Gilead operates in more than 35 countries worldwide, with headquarters in Foster City, California.Forward-Looking StatementsThis press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other factors, including Gilead's ability to initiate, progress or complete clinical trials within currently anticipated timelines or at all, and the possibility of unfavorable results from ongoing or additional clinical trials, including those involving Trodelvy; uncertainties relating to regulatory applications for Trodelvy and related filing and approval timelines, including the risk that the FDA may not grant full approval for Trodelvy for use in adult patients with locally advanced or metastatic UC who have previously received a platinum-containing chemotherapy and either a PD-1 or PD-L1 inhibitor, and pending or potential applications for the treatment of metastatic TNBC, mUC, HR+/HER2- breast cancer, NSCLC, SCLC, head and neck cancer, endometrial cancer and other cancers, in the currently anticipated timelines or at all; Gilead's ability to receive regulatory approvals for such indications in a timely manner or at all, and the risk that any such approvals may be subject to significant limitations on use; the possibility that Gilead may make a strategic decision to discontinue development of Trodelvy for such indications and as a result, Trodelvy may never be commercialized for these indications and any assumptions underlying any of the foregoing. These and other risks, uncertainties and other factors are described in detail in Gilead's Quarterly Report on Form 10-Q for the quarter ended September 30, 2022, as filed with the U.S. Securities and Exchange Commission. These risks, uncertainties and other factors could cause actual results to differ materially from those referred to in the forward-looking statements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, and is cautioned not to place undue reliance on these forward-looking statements. All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation and disclaims any intent to update any such forward-looking statements.Contact:Jacquie RossEmail: [email protected](C) 2023 Electronic News Publishing, source ENP Newswire